Thermogenenic Responses to Fasting and Overfeeding in Women

Launched by UNIVERSITY OF COLORADO, DENVER · Sep 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how fasting and overeating affect metabolism in women, particularly looking at why women tend to gain weight during and after menopause. As women go through menopause, they often gain weight, especially around the abdomen, which can lead to health issues like heart disease and diabetes. The researchers want to compare how the bodies of premenopausal women (those who still have their menstrual periods) and postmenopausal women (those who have not had a period for at least a year) react to not eating for 24 hours versus eating more than usual.

To participate in the study, women need to be between 18 and 45 years old if they are premenopausal, or at least 12 months postmenopausal if they are in the other group. Certain health conditions, such as obesity, diabetes, and thyroid issues, will exclude individuals from participating. If eligible, participants can expect to take part in tests that measure how their metabolism changes during fasting and overeating. This research could help us understand the changes that happen during menopause and how to better manage weight gain during this time.

Gender

FEMALE

Eligibility criteria

• • Inclusion criteria for premenopausal women
• • Age 18-45 years.
• • Regular menses (no missed cycles in the previous year; cycle length 25-35 d).
• • Inclusion criteria for postmenopausal women
• • No menses for at least 12 months
• • Follicular stimulating hormone (FSH) ≥50 mIU/ml.
• • Women who are within 2 years of the final menstrual period are preferred
• The primary exclusion criteria are:
• • Body mass index \> 30 kg/m2
• • Diabetes (fasting glucose \>126 mg/dL).
• • Thyroid dysfunction, defined as an ultrasensitive thyroid stimulating hormone (TSH) \<0.5 or \>5.0 mU/L
• • Uncontrolled hypertension defined as resting systolic BP \>150 mmHg or diastolic BP \>90 mmHg.
• • Additional exclusion criteria for postmenopausal women
• • History or current use of estrogen-based hormonal therapy
• • Women who have undergone surgical menopause.
• • Additional exclusion criteria for premenopausal women
• • Current hormonal contraceptive use (past 6 mo.).
• • Pregnant, lactating, or intention to become pregnant during the study period.
• • Participants who fail the thyroid and BP criteria will be considered for enrollment if they receive treatment for these conditions and are considered stable by their treating physician.